D-TechWorks - QMS Compliance Specialist

Description :

We are hiring for Architect Manager Lead (QMS Compliance Specialist ) - Hyderabad

Experience Requirements :

- Total Experience : 10 years

- Relevant Experience :

5-8 years of experience as a QMS compliance specialist and in QMS Administration

Role Overview :

We are seeking a skilled QMS Compliance Specialist II at the Manager level to support Quality Management System (QMS) integration, compliance, and continuous improvement initiatives. The role focuses on identifying gaps, ensuring regulatory compliance, and supporting system migrations in a highly regulated environment

Key Responsibilities :

- Assess QMS gaps against regulatory and quality standards such as ISO 13485 and 21 CFR 820 (QMSR).

- Develop, update, and maintain SOPs, work instructions, and quality records.

- Support QMS integration activities during mergers, acquisitions, divestitures, and system consolidations.

- Perform gap assessments between legacy systems and target-state QMS processes.

- Align and standardize quality processes, templates, and documentation across sites and functions.

- Support migration, implementation, and validation of electronic QMS (eQMS) systems ensuring data integrity and traceability.

- Provide quality guidance to project teams executing remediation and integration initiatives.

- Support management reviews and CAPA review boards with metrics, risk summaries, and remediation updates.

- Apply risk-based thinking to ensure compliance, product quality, and patient safety.

- Act as a site change analyst for both QMS and non-QMS processes.

Technical Skills :

Must Have :

- 610 years of experience in QMS administration and quality systems.

- Strong knowledge of ISO 13485 and FDA regulations including 21 CFR 820.

- Experience with QMS processes, documentation, and compliance frameworks.

Proficiency in :

- Microsoft Office Suite (Word, Excel, PowerPoint)

- SharePoint

- Ability to work independently with minimal supervision.

- Strong analytical mindset with problem-solving capabilities.

- Effective communication and stakeholder management skills.

Nice to Have :

- Lead Auditor Certification in ISO 13485.

- Experience in audit management.

- Exposure to eQMS platforms and system validation processes.

Qualifications :

- Bachelors degree in Engineering or related field (B.Tech preferred).

Soft Skills & Competencies :

- Ability to understand business needs and translate them into technical solutions

- Strong analytical and problem-solving skills

- Good communication and collaboration abilities

- Attention to detail with a focus on code quality

- Ability to work independently and in a team-oriented environment